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First Meeting of the Subcommittee of the Expert Committee on the Selection and Use of Essential Medicines
Geneva, 9-13 July 2007
The First Meeting of the Subcommittee of the Expert Committee on the Selection and Use of Essential Medicines will be held in Geneva from 9 to 13 July 2007. Applications for inclusion, change or deletion of a medicine in the Model List of Essential Medicines for Children had to be sent to the Secretary of the Subcommittee whose address is below before 15 May 2007. The Secretary of the First Meeting of the Subcommittee of the Expert Committee on the Selection and Use of Essential Medicines Policy, Access and Rational Use Department of Medicines Policy and Standards World Health Organization 20 Avenue Appia CH-1211 Geneva 27 Switzerland Public comments, including letters of support on the applications may be submitted to: emlsecretariat@who.int. All comments will also be published on the web. LATE PAPERS
Background information:
Application form for inclusion, change or deletion of a medicine Procedure to update and disseminate the WHO Model List of Essential Medicines Draft agenda for the Open Session (English // French) Draft agenda (English // French) WHA60.20: Better medicines for children EB121.R2: Expert Committee on the Selection and Use of Essential Medicines: establishment of a subcommittee
ITEM	Prepared by:	Comments

Criteria for the selection of essential medicines for children	Secretariat
Criteria for the selection of fixed-dose combinations for essential medicines for children	Secretariat
Paediatric age categories for essential medicines for children (DRAFT FOR DISCUSSION)	FIP: David Knoppert (Canada, Michael Reed (US), Sandra Benavides (US), Joyce Totton (Canada), David Hoff (US), Brady Moffett (US), Kelley Norris (US), Regis Vaillancourt (Canada), Robert Aucoin (US), Mary Worthington (US)
Position paper on off-label use of essential medicines for children	Madlen Gazarian MBBS, MSc(ClinEpi) FRACP, Sydney, Australia
Preferred dosage forms for essential medicines for children (DRAFT FOR DISCUSSION)	FIP: Regis Vaillancourt (Canada), David Knoppert (Canada), Michael Reed (US), Sandra Benavides (US), Joyce Totton (Canada), David Hoff (US), Brady Moffett (US), Kelley Norris (US)
Report on adherence to medications in children	Secretariat
Review of other medicines listed in WHO treatment guidelines for children	Secretariat
Review of regulatory initiatives designed to improve access to registered paediatric medicines:
Brief Selective History of Pediatric Initiatives in the United States of America	National Institute of Child Health and Human Development National Institutes of Health, Bethesda, USA
EU Paediatric Initiatives	Kalle Hoppu, MD PhD Poison Information Centre, Helsinki University Central Hospital, Hospital for Children and Adolescents and Dept. of Clinical Pharmacology, University of Helsinki, Helsinki, Finland
Review of the 1^st draft of model list for essential medicines for children Background document: Core list Complementary list Review of paediatric formulations for the 14th WHO Model Essential Medicine List -- Focus on parenteral, inhalational and topical preparations	Secretariat
APPLICATIONS
Abacavir (scored tablet 300 mg) (Section 6.4.2.1. Nucleoside/Nucleotide reverse transcriptase inhibitors)	GlaxoSmithKline (GSK)
Antifungal medicines	Secretariat
Artemether (20 mg/ml for intramuscular administration) (Section 6.5.3.1. Antimalarial medicines, for curative treatment)	Dr F.H. Jansen, Medical and R&D Director, Dafra Pharma nv, Slachthuisstraat 30 bus 7, B-2300 Turnhout, Belgium
Artemether + lumefantrine (paediatric powder for oral liquid) (Section 6.5.3.1. Antimalarial medicines, for curative treatment)	Dr F.H. Jansen, Medical and R&D Director, Dafra Pharma nv, Slachthuisstraat 30 bus 7, B-2300 Turnhout, Belgium
Artesunate (Rectal capsules containing 50 mg and 200 mg sodium artesunate) (Section 6.5.3 - Antimalarial medicines) Letter re legal status of above-mentioned rectal application forms	Dr P. Olumese, Global Malaria Programme
Artesunate + amodiaquine fixed-dose combination (25 mg/ 67.5 mg, 50 mg/ 135 mg and 100 mg/270 mg) (Section 6.5.3.1. Antimalarial medicines, for curative treatment) References: Evaluation de l efficacite et de la tolerance de l amodiaquine versus chloroquine dans le traitement de l acces palustre simple chez l enfant au Gabon. Artemisinins: mechanisms of action and potential for resistance. Artesunate combinations for treatment of malaria: meta-analysis. Amodiaquine-artesunate versus amodiaquine for uncomplicated Plasmodium falciparum malaria in African children: a randomised, multicentre trial. ATAQ EASY Coarsucam® versus Coartem® for uncomplicated Plasmodium falciparummalaria A multinational, randomized study comparing the tolerability and efficacy	SANOFI-AVENTIS
Artesunate + mefloquine fixed-dose combination (Artequin™ Paediatric Stickpacks containing 50 mg artesunate + 125 mg mefloquine each) (Section 6.5.3.1. Antimalarial medicines, for curative treatment) Clinical summary // Clinical overview	Dieter Meppiel, International Product Manager Malaria, Mepha Ltd., CH-4147 Aesch
Lamivudine (scored tablet 150 mg) (Section 6.4.2.1. Antiretrovirals, Nucleoside/Nucleotide reverse transcriptase inhibitors)	GlaxoSmithKline (GSK)
Lamivudine + stavudine + nevirapine fixed-dose combination 40 mg + 10 mg + 70 mg (tablet for oral liquid) 20 mg + 5 mg + 35 mg (tablet for oral liquid) (Section 6.4.2. Antiretrovirals, fixed-dose combinations)	Ranbaxy Laboratories Limited, India
Lamivudine + zidovudine + nevirapine fixed-dose combination (tablet for oral liquid: 30 mg + 60 mg + 60 mg) (Section 6.4.2. Antiretrovirals, fixed-dose combinations)	Ranbaxy Laboratories Limited, India
Racecadotril Children of 3 months to 2 years of age: 16 sachets of 1 g powder containing 10 mg of racecadotril Children of 2 years to 15 years of age (approx.) : 16 or 30 sachets of 3 g powder containing 30 mg of racecadotril Racecadotril (Summary) Tiorfan/Hidrasec® (PowerPoint presentation) Racecadotril in the treatment of acute watery diarrhea in children, Salazar-Lindo E, et al. Efficacy and Tolerability of Racecadotril in Acute Diarrhea in Children, Cezard JP et al.	Jean-Guillaume Lecomte, Bioprojet Pharma, France
Respiratory tract infections, especially in children with HIV	Secretariat
Review of chloramphenicol injection	Secretariat
Subcutaneous immunoglobulin // Covering letter (Section 11.2: Plasma fractions for specific use) Appendix A: Clinical study // Appendix B: Patients’ views on subcutaneous IgG (SCIG) Home Therapy // Appendix C: Safety // Appendix D: Effectiveness // Appendix E: Cost-effectiveness // Appendix F: Further experience with subcutaneous immunoglobulin therapy in children with primary immune deficiencies International availability // EMEA: Core SPC for human normal immunoglobulin for subcutaneous and intramuscular use Formulary text	International Union of Immunological Societies [IUIS]
Update on oral rehydration solution constituents JAMA article: Symptomatic Hyponatremia During Treatment of Dehydrating Diarrheal Disease With Reduced Osmolarity Oral Rehydration Solution	Secretariat
Zidovudine/lamivudine fixed-dose combination AZT/3TC (scored tablet 300/150 mg) (Section 6.4.2. Antiretrovirals, fixed-dose combinations)	GlaxoSmithKline (GSK)